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Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

NCT00800683 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2014-05-20

Study results available
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Summary

to determine safety, efficacy and tolerability of BI 1356 versus placebo

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

BI 1356

BI 1356 dosed once daily

DRUG

placebo

placebo matching BI 1356 taken once daily

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-01-31

Countries

  • United States
  • Australia
  • Hong Kong
  • Israel
  • New Zealand
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800683 on ClinicalTrials.gov